BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PELTIERTHERAPY(C) HEAT/COLD TREATMENT

    K Number: K871112 · Decision May 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    1
    Applicant Total
    44
    Review Days
    48

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    Basic Information

    Device Name
    PELTIERTHERAPY(C) HEAT/COLD TREATMENT
    K Number
    K871112
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5940
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Henley Intl.
    Date Received
    March 19, 1987
    Decision Date
    May 6, 1987
    Product Code
    IMF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IMF Unit, Chilling

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